ANDA 206581, held by Perrigo R And D. Ibuprofen Sodium.
As of Nov 15, 2026, ANDA 206581 (Ibuprofen Sodium), held by Perrigo R And D, was first approved by FDA on Aug 3, 2015, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 3, 2015 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ibuprofen SodiumEQ 200MG BASE ยท tablet;oral | Ibuprofen Sodium | Discontinued |
| Feb 19, 2016 | Supplement 1Manufacturing | Approved | None posted |
| Aug 3, 2015 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
